Study of the therapeutic effects of curcumin gel after gum repair surgery
| ISRCTN | ISRCTN14159005 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14159005 |
| Secondary identifying numbers | 3078 |
- Submission date
- 15/12/2020
- Registration date
- 23/12/2020
- Last edited
- 24/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Free gingival grafts – when healthy tissue from the roof of your mouth is attached to your teeth where the root is exposed can prevent any further loss of gum tissue and it can help with sensitivity.
The spice turmeric contains a substance called curcumin, which has long been used in Asian medicine and is linked to health benefits.
This study aims to evaluate the therapeutic effect of curcumin extract and comparing using it or gingival dressing after grafting surgery.
Who can participate?
Healthy adults aged 18 - 45 years who are non-smokers
What does the study involve?
Piece of gum will be grafted and sutured for each group. One group will receive curcumin gel and the other will receive gingival dressing. The size of the grafts, their healing and the patient's pain will be assessed afterwards.
What are the possible benefits and risks of participating?
Both are safe and should not cause any additional risks, other than those involved in the gum grafting procedure. All participants will receive the same treatment.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
October 2020 to January 2022
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Zuhir Alasfar, zuhiralasfar@gmail.com
Contact information
Scientific
Ruken aldean
Assadeddin Rd
Building N.27
Damascus
-
Syria
 ORCID ID |
0000-0002-6372-0094 |
|---|---|
| Phone | +963 941952181 |
| zuhiralasfar@gmail.com |
Study information
| Study design | Single centre clinical comparative randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Evaluation of the usage of extracted curcumin in the healing of free gingival graft and donor site palatal wound |
| Study objectives | To test the therapeutic effect of curcumin extracted gel, and comparing it to gingival dressing after free gingival graft surgery |
| Ethics approval(s) | Approved 09/10/2020, Ethics Committee- Dental College- Damascus University (Mazzeh Highway, Damascus, Syria; +963 1133923486; sr.srd@damasuniv.edu.sy), ref: no.3889 |
| Health condition(s) or problem(s) studied | Free gingival (gum) treatment for absence or insufficiency of attached gingiva |
| Intervention | All participants undergo free gingival graft surgery In the test group, we will apply curcumin gel in the donor and recipient site for 7 days after surgery. In the control group, we will apply gingival dressing in the donor and recipient site. The size of the grafts, their healing and the patient's pain will be assessed afterwards for 3 months. Randomization method: flipping a coin. |
| Intervention type | Supplement |
| Primary outcome measure | Shrinkage of the graft assessed using at 2 months, 3 months and 6 months. A standard sizing template of known size is placed beside the graft and digital photographs are taken. Software is used to calculate the size of the graft by comparing it with the template in the images |
| Secondary outcome measures | 1. Shrinkage of the graft assessed using at 2 months, 3 months and 1. Recipient site healing assessed using the modified early-wound healing index (MEHI) at 1 week, 2 weeks, 1 month and 2 months 2. Recipient site pain assessed by the patient using a 1-10 visual analogue scale at 6 h, 12 h, 24 h, 2 days, 3 days, 4 days, 5 days, 6 days and 7 days after surgery |
| Overall study start date | 09/10/2020 |
| Completion date | 01/01/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Attached gingiva ≤1 mm 2. No systemic diseases 3. Non-smoker 4. Gingival inflammation and plaque indexes <20% at time of surgery 5. Aged 18 - 45 years |
| Key exclusion criteria | 1. Systemic disease that would interfere with the healing process 2. Has undergone previous periodontal surgery 3. Tooth mobility 4. Pregnant 5. Radiation-exposed 6. Alcoholic 7. Receiving diuretic treatment 8. Taking hormone alternatives 9. Immunocompromised |
| Date of first enrolment | 02/12/2020 |
| Date of final enrolment | 01/12/2021 |
Locations
Countries of recruitment
- Syria
Study participating centre
Mazzah High Way
Damascus
DM20AM18
Syria
Sponsor information
University/education
Al-mazzeh highway
Damascus
DM20AM18
Syria
| Phone | +963 112121635 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://damasuniv.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | After finishing the follow up procedure and writing the article, I am planning to publish it (with all results, statistical analysis and some photos) in Damascus University's journal, and many other international journals. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Editorial Notes
24/12/2020: Internal review.
23/12/2020: Trial’s existence confirmed by Damascus University
